A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease

Phase 4

Completed

• Conditions: Alzheimer Disease
• Interventions: Dietary Supplement: caprylidene; Dietary Supplement: Placebo

• Registration Number: NCT01122329
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission tomography prior to and 90 minutes after consumption of Axona® at baseline and then again after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Study Start: 2010-10
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Diagnosis of probable AD (NINDS-ADRDA criteria(32))
• Age 50 - 90 (inclusive)
• MMSE range: 10 to 28
• Participants may be taking medications for AD, provided that the dose of these medications has been stable for > 90 days
• Proficiency in English to be able to perform cognitive tests
• A caregiver must be available to monitor and administer treatment and to accompany the subject to every clinical visit.

Exclusion Criteria

• Inability for any reason to undergo PET/CT scans
• Previous treatment with AC-1202
• Allergic to milk or soy
• Presence of neurodegenerative disease other than AD
• History of stroke or other injury that could result in cognitive impairment
• Psychiatric disorder
• Diabetes mellitus
• Recent (<90 days) changes to medications prescribed for cognitive reasons or with the potential to impact cognition
• Irritable bowel syndrome (IBS) or other gastrointestinal conditions that could interfere with treatment compliance
• Any factor deemed by the investigator to be likely to interfere with study conduction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axona®	caprylidene	-
inactive food packet	Placebo	-

Primary Outcome Measures

Name	Time	Method
Regional cerebral blood flow (rCBF)	45 days after initation of treatment with Axona®

Secondary Outcome Measures

Name	Time	Method
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition	45 days after initiation of treatment with Axona®
To examine the effect of AC-1202 on cognition	45 days after initiation of treatment with Axona®

Trial Locations

Locations (2)

200 Medical Plaza, UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Center for Neurotherapeutics at UCLA; 🇺🇸 Los Angeles, California, United States